Representative batches? [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2010-08-04 23:42 (4009 d 01:37 ago) – Posting: # 5719
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Dear ElMaestro,

nice summary; couldn’t agree more.
Section 4.1.2 of the BE-GL: “representative” appears three times and “justify/justification” five times. ;-)

In the past sponsors tried to select T & R batches which matched closely in vitro (content & dissolution). If BE could be demonstrated, everybody was happy (believing that the “selection” worked). If not, most people did rather not question the (lacking) discriminatory power of the in vitro method, but sighed and said “Well, we have to face that it did not work in in vivo – but it’s well known, that without IVIVC, etc. etc.”

I have strong doubts that it is possible to justify that a batch is representative – if we move away from pharmaceutical quality and start thinking about BE.


I changed the category; doesn’t look as a statistical issue to me (any more). [Helmut]

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